Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.

Influenza H1N1 Vaccination in Mixed Connective Tissue Disease: Effectiveness and Safety Independent of Disease or Therapy.

Miossi1,  Renata, Fuller1,  Ricardo, Moraes1,  Julio C. B., Medeiros1,  Ana Cristina, Saad1,  Carla G.S., Aikawa1,  Nadia E., Miraglia2,  Joao

University of Sao Paulo, Sao Paulo, Brazil
Fundação Butantan, São Paulo, Brazil
Adolfo Lutz Institute, Sao Paulo, Brazil


There are specific recommendations for influenza vaccination in systemic autoimmune diseases and the WHO recently recommended that the 2010–2011 trivalent seasonal flu vaccine must contain the A/California/7/2009 (H1N1) virus. With regard to mixed connective tissue disease (MCTD) there is only one study in the literature from our group focusing solely in vaccine side-effects and the overall immunoresponse in large cohort of rheumatic diseases (Ann Rheum Dis. 70(6): 1068–73, 2011). We therefore evaluated herein the possibility of clinical and laboratorial disease exacerbation as well as the influence of disease manifestations and therapy in antibody response.


From March 22 to April 02, 2010, 69 subjects diagnosed with MCTD according to Kasukawa's classification criteria and 69 age and gender matched controls were vaccinated with non-adjuvanted influenza A/California/7/2009 (H1N1) virus-like strain. Patients were clinically evaluated and blood samples (inflammatory markers, muscle enzymes) were collected pre- and 21 days post-vaccination. Anti-H1N1 titers were determined by influenza hemagglutination inhibition assay. The percentage of seroprotection (SP), seroconversion (SC) and the factor increase in geometric mean titer (GMT) were calculated.


Mean age (48.6 ±12.6 vs. 48±12, P=0.68) and female gender predominance (95.6%) were alike in patients and controls. The mean disease duration was 12.9±8.9 years. A comparable SP (10.1 vs. 10.1%, P=1), SC (66.7% vs. 65.2%, P=1) and factor increase GMT (10; 95%CI, 7.1–14.1 vs. 8; 95%CI, 6–10.6; P=0.33) was observed in patients and controls. The specific analysis of immunosuppressive therapy influence (prednisone>=7,5mg/day and/or cytotoxic drugs) revealed a similar SC rate in patients with and without these drugs (72.7% vs. 56.0%, P=0.19). Moreover, the SC rate in the only 7 patients with prednisone>=20mg/day were similar to controls (P=0.69). Patients, at entry, with and without current pulmonary disease (P=0.62), pulmonary arterial hypertension (P=0.75) had comparable SC rates. Laboratorial parameters remained stable pre- and post vaccine: CRP (P=0.55), CPK (P=0.31), aldolase (P=0.4). Of note, none of the patients presented deterioration of the clinical disease. No major severe side effects were reported.


The non-adjuvanted influenza A/H1N1 vaccination immunoresponse in MCTD patients is adequate and independent of disease manifestations and therapy. In addition, the observed overall disease clinical and laboratorial safety settles its recommendation.

To cite this abstract, please use the following information:
Miossi, Renata, Fuller, Ricardo, Moraes, Julio C. B., Medeiros, Ana Cristina, Saad, Carla G.S., Aikawa, Nadia E., et al; Influenza H1N1 Vaccination in Mixed Connective Tissue Disease: Effectiveness and Safety Independent of Disease or Therapy. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :709

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